Neurophysiologic monitoring system
The present invention relates to a system and methods generally aimed at surgery. More particularly, the present invention is directed at a system and related methods for performing surgical procedures and assessments involving the use of neurophysiology.
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The present application is an Non Provisional patent application of and claims the benefit of priority from commonly owned and U.S. Provisional Patent Application Ser. Nos. 60/921,781, filed Apr. 4, 2007, entitled “Neurophysiologic Monitoring System,” and 61/000,354, filed Oct. 24, 2007, entitled “System and Methods for Performing Neurophysiologic Assessments,” the entire contents each of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein.BACKGROUND OF THE INVENTION
I. Field of the Invention
The present invention relates to a system and methods generally aimed at surgery. More particularly, the present invention is directed at a system and related methods for performing surgical procedures and assessments involving the use of neurophysiology.
II. Description of Related Art
Neurophysiology monitoring has become an increasingly important adjunct to surgical procedures where neural tissue may be at risk. Spinal surgery, in particular, involves working close to delicate tissue in and surrounding the spine, which can be damaged in any number of different ways. For example, an exiting nerve root may be comprised if surgical instruments have to pass near or close to the nerve while accessing the surgical target site in the spine. A spinal nerve and/or exiting nerve root may also be compromised if a pedicle screw, used often to secure fixation of multiple vertebra relative to each other, breaches the cortical layer of the pedicle. Surgeries targeting the spine may also require the retraction of nerve and/or vascular tissue out of the operative corridor. While doing so is necessary, there is a possibility of damaging nerve tissue through over retraction and/or a decreased supply of blood reaching the tissue due to the impingement of the retractor against the vascular tissue. Various neurophysiological techniques have been attempted and developed to monitor delicate nerve tissue during surgery in attempts to reduce the risk inherent in spine surgery (and surgery in general). Because of the complex structure of the spine and nervous system no single monitoring technique has been developed that may adequately assess the risk to nervous tissue in all situations and complex techniques are often utilized in conjunction one or more other complex monitoring techniques. EMG monitoring, for example, may be used to detect the presence of nerve roots near a surgical instrument or a breach formed in a pedicle wall. EMG monitoring is not, however, very effective when cord monitoring is required.
When cord monitoring is required one of motor evoked potential (MEP) and somatosensory evoked potential (SSEP) monitoring is often chosen. While both MEP and SSEP monitoring can be quite effective, MEP monitors the ventral column of the spinal cord and SSEP monitors the dorsal column. Danger to nerve tissue that might then be detected using one these methods may be missed by the other, and vice versa. Thus it may be most effective to use both MEP and SSEP monitoring during the same procedure, while still potentially needing EMG monitoring as well.
EMG, MEP, and SSEP involve complex analysis and specially trained neurophysiologists are generally called upon to perform the monitoring. Even though performed by specialists, interpreting the complex waveforms in this fashion is nonetheless disadvantageously prone to human error and can be disadvantageously time consuming, adding to the duration of the operation and translating into increased health care costs. Even more costly is the fact that the neurophysiologist is required in addition to the actual surgeon performing the spinal operation. Putting the difficulties associated with human interpretation of EMG, MEP, and SSEP monitoring aside, combining such testing in the OR generally requires multiple products to accommodate t the differing requirements of each. This is disadvantageous when space is often as such a premium in the operating rooms of today. The present invention is directed at eliminating, or at least reducing the effects of, the above-described problems with the prior art.SUMMARY OF THE INVENTION
The present invention includes a system and methods for avoiding harm to neural tissue during surgery. According to a broad aspect, the present invention includes an instrument capable of advancement to a surgical target site and a processing system. The instrument is configured to deliver a stimulation signal either while advancing to the target site and after reaching said target site. The processing system is programmed with a set of at least three threshold ranges and configured to direct a first stimulation signal to said instrument at a first magnitude. The first magnitude corresponds to a boundary between the pair of ranges. The processing system further directs a second stimulation signal at a second magnitude corresponding to a boundary between a different pair of the ranges. The processing unit is still further programmed to and measure the response of nerves depolarized by said stimulation signals to indicate at least one of nerve proximity and pedicle integrity.
According to another broad aspect, the present invention includes a control unit, a patient module, and a plurality of surgical accessories adapted to couple to the patient module. The control unit includes a power supply and is programmed to receive user commands, activate stimulation in a plurality of predetermined modes, process signal data according to defined algorithms, display received parameters and processed data, and monitor system status. The patient module is in communication with the control unit. The patient module is within the sterile field. The patient module includes signal conditioning circuitry, stimulator drive circuitry, and signal conditioning circuitry required to perform said stimulation in said predetermined modes. The patient module includes a processor programmed to perform a plurality of predetermined functions including at least two of static pedicle integrity testing, dynamic pedicle integrity testing, nerve proximity detection, neuromuscular pathway assessment, manual motor evoked potential monitoring, automatic motor evoked potential monitoring, somatosensory evoked potential monitoring, non-evoked monitoring, and surgical navigation.
According to still another broad aspect, the present invention includes an instrument and a processing system. The instrument is in communication with the processing unit. The instrument is capable of advancement to a surgical target site and is configured to deliver a stimulation signal at least one of while advancing to said target site and after reaching said target site. The processing unit is programmed to perform a plurality of predetermined functions using said instrument including at least two of static pedicle integrity testing, dynamic pedicle integrity testing, nerve proximity detection, neuromuscular pathway assessment, manual motor evoked potential monitoring, automatic motor evoked potential monitoring, somatosensory evoked potential monitoring, non-evoked monitoring, and surgical navigation. The processing system has a pre-established profile for at least one of said predetermined functions so as to facilitate the initiation of said at least one predetermined function.
Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
A surgeon operable neurophysiology system 10 is described herein and is capable of performing a number of neurophysiological and/or guidance assessments at the direction of the surgeon (and/or other members of the surgical staff). By way of example only,
In one embodiment, the neurophysiology system 10 may be configured to execute any of the functional modes including, but not necessarily limited to, static pedicle integrity testing (“Basic Stimulated EMG”), dynamic pedicle integrity testing (“Dynamic Stimulated EMG”), nerve proximity detection (“XLIF®”), neuromuscular pathway assessment (“Twitch Test”), motor evoked potential monitoring (“MEP manual” and “MEP Automatic”), somatosensory evoked potential monitoring (“SSEP”), non-evoked monitoring (“Free-run EMG”) and surgical navigation (“Navigated Guidance”). The neurophysiology system 10 may also be configured for performance in any of the lumbar, thoracolumbar, and cervical regions of the spine.
The basis for performing many of these functional modes (e.g. Basic Stimulated EMG, Dynamic Stimulated EMG, XLIF, MEP manual, and MEP automatic, and Twitch Test) is the assessment of evoked responses of the various muscles myotomes monitored by the system 10 in relation to a stimulation signal transmitted by the system 10 (via patient module 14). This is illustrated in
Before further addressing Ithresh and the various functional modes of the surgical system 10, the hardware components and features of the system 10 will be describe in further detail. The control unit 12 of the neurophysiology system 10, illustrated by way of example only in
The patient module 14, shown by way of example only in
With reference to
As soon as a device is plugged into any one of ports 50, 52, 56, or 58, the neurophysiology system 10 automatically performs a circuit continuity check to ensure the associated device will work properly. Each device forms a separate closed circuit with the patient module such that the devices may be checked independent of each other. If one device is not working properly the device may be identified individually while the remaining devices continue indicate their valid status. An indicator LED is provided for each port to convey the results of the continuity check to the user. Thus, according to the example embodiment of
To connect the array of recording electrodes 24 and stimulation electrodes 22 utilized by the system 10, the patient module 14 also includes a plurality of electrode harness ports. In the embodiment shown, the patient module 14 includes an EMG/MEP harness port 72, SSEP harness port 74, and an Auxiliary harness port 76 (for expansion and/or custom harnesses). Each harness port 72, 74, and 76 includes a shaped socket 78 that corresponds to a matching shaped connector 82 on the appropriate electrode harness 80. In addition, the neurophysiology system 10 may preferably employ a color code system wherein each modality (e.g. EMG, EMG/MEP, and SSEP) has a unique color associated with it. By way of example only and as shown herein, EMG monitoring (including, screw tests, detection, and nerve retractor) may be associated with the color green, MEP monitoring with the color blue, and SSEP monitoring may be associated with the color orange. Thus, each harness port 72, 74, 76 is marked with the appropriate color which will also correspond to the appropriate harness 80. Utilizing the combination of the dedicated color code and the shaped socket/connector interface simplifies the setup of the system, reduces errors, and can greatly minimize the amount of pre-operative preparation necessary. The patient module 14, and especially the configuration of quantity and layout of the various ports and indicators, has been described according to one example embodiment of the present invention. It should be appreciated, however, that the patient module 14 could be configured with any number of different arrangements without departing from the scope of the invention.
As mentioned above, to simplify setup of the system 10, all of the recording electrodes 24 and stimulation electrodes 22 that are required to perform one of the various functional modes (including a common electrode 23 providing a ground reference to pre-amplifiers in the patient module 14, and an anode electrode 25 providing a return path for the stimulation current) are bundled together and provided in single electrode harness 80, as illustrated, by way of example only, in
At one end of the harness 80 is the shaped connector 82. As described above, the shaped connector 82 interfaces with the shaped socket 72, 74, or 76 (depending on the functions harness 80 is provided for). Each harness 80 utilizes a shaped connector 82 that corresponds to the appropriate shaped socket 72, 74, 76 on the patient module 14. If the shapes of the socket and connector do not match the harness 80, connection to the patient module 14 cannot be established. According to one embodiment, the EMG and the EMG/MEP harnesses both plug into the EMG/MEP harness port 72 and thus they both utilized the same shaped connector 82. By way of example only,
To facilitate easy placement of scalp electrodes used during MEP and SSEP modes, an electrode cap 81, depicted by way of example only in
To further simplify the process of placing the required electrodes, the end of each wire lead next to the electrode connector 102 may be tagged with a label 86 that shows or describes the proper positioning of the electrode on the patient. The label 86 preferably demonstrates proper electrode placement graphically and textually. As shown in
The patient module 14 is configured such that the neurophysiology system 10 may conduct an impedance test under the direction of the control unit 12 of all electrodes once the system is set up and the electrode harness is connected and applied to the patient. After choosing the appropriate spinal site upon program startup (described below), the user is directed to an electrode test.
The neurophysiology system 10 may utilize various stimulation accessories to deliver stimulation signals to a stimulation target site, such as a hole formed or being formed in a pedicle and/or tissue surrounding a surgical access corridor. One such stimulation accessory is the stimulation probe 16, illustrated, by way of example, in
Also situated in the handle 116 of probe 16 is a multi-color LED light 124. The LED 124 may be used to indicate the connectivity status of the probe. This may be done preferably, in addition to the connectivity status indicated from the accessory indicator 62. When the probe 16 is connected to the patient module 14 stimulation is active the LED 124 may appear predetermined color (e.g. purple in this embodiment) to indicate the stimulation status. Additionally, the LED 124 may be used to indicate the status of a threshold (Ithresh) result. By way of example, and as will be further described below, if a threshold value is determined to be within a predetermined safe range, the probe LED 124 may appear the color green indicating relative safety. If the determined threshold value falls within a predetermined unsafe range, the probe LED 124 may appear the color red indicating potential danger. Finally, if the threshold result is between the predetermined safe and unsafe ranges, the probe LED may appear yellow indicating caution. The probe handle 116 may also be equipped to emit audible tones related to the determined threshold results. For example, the pitch of the sound may change in response to different threshold levels. Thus, when a determined threshold is in the safe (Green) range then a low pitch tone may be emitted. When the threshold result is in-between the safe and unsafe levels (Yellow) the sound may have a higher pitch. A still higher pitch may be emitted when the threshold result is in the unsafe (Red) range. Alternatively, a different sound volume may indicate different safety levels. In still another alternative, different sounds (e.g. ping, bell, siren etc. . . . ) may be produced for each safety level. The probe handle 116 may also be equipped to deliver tactile feedback to the user. For example, the probe handle 116 may vibrate in response to a determined stimulation threshold. The vibration of the probe 116 may operate in similar fashion to that of the sound function just described. That is, the vibration frequency and/or intensity may be altered depending on the safety level of the corresponding threshold result. Any of the vibration frequency, intensity, pulse pattern, etc. . . . may be variable depending upon the stimulation result so as to provide an indication to the user of the determined threshold. The stimulation probe 116 includes a connector 126 that may be plugged into one of the accessory ports 62 on the patient module 14. Similar to the electrode connector 82, the probe connector 126 includes an identification signal that identifies the probe 116 to the patient module 14.
As mentioned above, the neurophysiology monitoring system 10 may include a secondary display, such as for example only, the secondary display 46 illustrated in
Having described an example embodiment of the system 10 and the hardware components that comprise it, the neurophysiological functionality and methodology of the system 10 will now be described in further detail. Various parameters and configurations of the neuromonitoring system 10 may depend upon the target location, i.e. spinal region, of the surgical procedure. In one embodiment, upon starting the system 10 the software will automatically open to the startup screen, illustrated by way of example only, in block chart form in
The information displayed on the monitoring screen may include, but is not necessarily limited to, alpha-numeric and/or graphical information regarding any of the functional modes (e.g., Basic Stimulated EMG, Dynamic Stimulated EMG, XLIF, MEP automatic, MEP manual, SSEP, Twitch Test, and Free run), attached accessories (e.g. stimulation probe 16, stimulation clip 18, tilt sensor 54), electrode harness or harnesses attached, impedance test results, myotome/EMG levels, stimulation levels, history reports, selected parameters, test results, etc. . . . In one embodiment, set forth by way of example only, this information displayed on a main monitoring screen may include, but is not necessarily limited to the following components as set forth in Table 6:
With reference to
From a profile setting screen 154, illustrated by way of example only in
The functions performed by the neuromonitoring system 10 may include, but are not necessarily limited to, the Twitch Test, Free-run EMG, Basic Stimulated EMG, Dynamic Stimulated EMG, XLIF®, Nerve Retractor, MEP Auto, MEP manual, and SSEP modes, all of which will be described briefly below. The system 10 further includes a navigated guidance function that will also be described below. The Twitch Test mode is designed to assess the neuromuscular pathway via the so-called “train-of-four test” to ensure the neuromuscular pathway is free from muscle relaxants prior to performing neurophysiology-based testing, such as bone integrity (e.g. pedicle) testing, nerve detection, and nerve retraction. This is described in greater detail within PCT Patent App. No. PCT/US2005/036089, entitled “System and Methods for Assessing the Neuromuscular Pathway Prior to Nerve Testing,” filed Oct. 7, 2005, the entire contents of which is hereby incorporated by reference as if set forth fully herein. The Basic Stimulated EMG Dynamic Stimulated EMG tests are designed to assess the integrity of bone (e.g. pedicle) during all aspects of pilot hole formation (e.g., via an awl), pilot hole preparation (e.g. via a tap), and screw introduction (during and after). These modes are described in greater detail in PCT Patent App. No. PCT/US02/35047 entitled “System and Methods for Performing Percutaneous Pedicle Integrity Assessments,” filed on Oct. 30, 2002, and PCT Patent App. No. PCT/US2004/025550, entitled “System and Methods for Performing Dynamic Pedicle Integrity Assessments,” filed on Aug. 5, 2004 the entire contents of which are both hereby incorporated by reference as if set forth fully herein. The XLIF mode is designed to detect the presence of nerves during the use of the various surgical access instruments of the neuromonitoring system 10, including the pedicle access needle 26, k-wire 42, dilator 44, and retractor assembly 70. This mode is described in greater detail within PCT Patent App. No. PCT/US2002/22247, entitled “System and Methods for Determining Nerve Proximity, Direction, and Pathology During Surgery,” filed on Jul. 11, 2002, the entire contents of which is hereby incorporated by reference as if set forth fully herein. The Nerve Retractor mode is designed to assess the health or pathology of a nerve before, during, and after retraction of the nerve during a surgical procedure. This mode is described in greater detail within PCT Patent App. No. PCT/US2002/30617, entitled “System and Methods for Performing Surgical Procedures and Assessments,” filed on Sep. 25, 2002, the entire contents of which are hereby incorporated by reference as if set forth fully herein. The MEP Auto and MEP Manual modes are designed to test the motor pathway to detect potential damage to the spinal cord by stimulating the motor cortex in the brain and recording the resulting EMG response of various muscles in the upper and lower extremities. The SSEP function is designed to test the sensory pathway to detect potential damage to the spinal cord by stimulating peripheral nerves inferior to the target spinal level and recording the action potential from sensors superior to the spinal level. The MEP Auto, MEP manual, and SSEP modes are described in greater detail within PCT Patent App. No. PCT/US2006/003966, entitled “System and Methods for Performing Neurophysiologic Assessments During Spine Surgery,” filed on Feb. 2, 2006, the entire contents of which is hereby incorporated by reference as if set forth fully herein. The Navigated Guidance function is designed to facilitate the safe and reproducible use of surgical instruments and/or implants by providing the ability to determine the optimal or desired trajectory for surgical instruments and/or implants and monitor the trajectory of surgical instruments and/or implants during surgery. This mode is described in greater detail within PCT Patent App. No. PCT/US2007/11962, entitled “Surgical Trajectory Monitoring System and Related Methods,” filed on Jul. 30, 2007, the entire contents of which are incorporated herein by reference as if set forth fully herein. These functions will be explained now in brief detail.
The neuromonitoring system 10 performs neuromuscular pathway (NMP) assessments, via Twitch Test mode, by electrically stimulating a peripheral nerve (preferably the Peroneal Nerve for lumbar and thoracolumbar applications and the Median Nerve for cervical applications) via stimulation electrodes 22 contained in the applicable electrode harness and placed on the skin over the nerve or by direct stimulation of a spinal nerve using a surgical accessory such as the probe 116. Evoked responses from the muscles innervated by the stimulated nerve are detected and recorded, the results of which are analyzed and a relationship between at least two responses or a stimulation signal and a response is identified. The identified relationship provides an indication of the current state of the NMP. The identified relationship may include, but is not necessarily limited to, one or more of magnitude ratios between multiple evoked responses and the presence or absence of an evoked response relative to a given stimulation signal or signals. With reference to
The neuromonitoring system 10 may test the integrity of pedicle holes (during and/or after formation) and/or screws (during and/or after introduction) via the Basic Stimulation EMG and Dynamic Stimulation EMG tests. To perform the Basic Stimulation EMG a test probe 116 is placed in the screw hole prior to screw insertion or placed on the installed screw head and a stimulation signal is applied. The insulating character of bone will prevent the stimulation current, up to a certain amplitude, from communicating with the nerve, thus resulting in a relatively high Ithresh, as determined via the basic threshold hunting algorithm described below. However, in the event the pedicle wall has been breached by the screw or tap, the current density in the breach area will increase to the point that the stimulation current will pass through to the adjacent nerve roots and they will depolarize at a lower stimulation current, thus Ithresh will be relatively low. The system described herein may exploit this knowledge to inform the practitioner of the current Ithresh of the tested screw to determine if the pilot hole or screw has breached the pedicle wall.
In Dynamic Stim EMG mode, test probe 116 may be replaced with a clip 18 which may be utilized to couple a surgical tool, such as for example, a tap member 28 or a pedicle access needle 26, to the neuromonitoring system 10. In this manner, a stimulation signal may be passed through the surgical tool and pedicle integrity testing can be performed while the tool is in use. Thus, testing may be performed during pilot hole formation by coupling the access needle 26 to the neuromonitoring system 10, and during pilot hole preparation by coupling the tap 28 to the system 10. Likewise, by coupling a pedicle screw to the neuromonitoring system 10 (such as via pedicle screw instrumentation), integrity testing may be performed during screw introduction.
In both Basic Stimulation EMG mode and Dynamic Stimulation EMG mode, the signal characteristics used for testing in the lumbar testing may not be effective when monitoring in the thoracic and/or cervical levels because of the proximity of the spinal cord to thoracic and cervical pedicles. Whereas a breach formed in a pedicle of the lumbar spine results in stimulation being applied to a nerve root, a breach in a thoracic or cervical pedicle may result in stimulation of the spinal cord instead, but the spinal cord may not respond to a stimulation signal the same way the nerve root would. To account for this, the surgical system 10 is equipped to deliver stimulation signals having different characteristics based on the region selected. By way of example only, when the lumbar region is selected, stimulation signals for the stimulated EMG modes comprise single pulse signals (see
Stimulation results (including but not necessarily limited to at least one of the numerical Ithresh value and color coded safety level indication) and other relevant data are conveyed to the user on at least main display 34, as illustrated in
The neuromonitoring system 10 may perform nerve proximity testing, via the XLIF mode, to ensure safe and reproducible access to surgical target sites. Using the surgical access components 26-32, the system 10 detects the existence of neural structures before, during, and after the establishment of an operative corridor through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient. The surgical access components 26-32 are designed to bluntly dissect the tissue between the patient's skin and the surgical target site. Dilators of increasing diameter, which are equipped with one or more stimulating electrodes, are advanced towards the target site until a sufficient operating corridor is established to advance retractor 32 to the target site. As the dilators are advanced to the target site electrical stimulation signals are emitted via the stimulation electrodes. The stimulation signal will stimulate nerves in close proximity to the stimulation electrode and the corresponding EMG response is monitored. As a nerve gets closer to the stimulation electrode, the stimulation current required to evoke a muscle response decreases because the resistance caused by human tissue will decrease, and it will take less current to cause nervous tissue to depolarize. Ithresh is calculated, using the basic threshold hunting algorithm described below, providing a measure of the communication between the stimulation signal and the nerve and thus giving a relative indication of the proximity between access components and nerves. An example of the monitoring screen 200 with XLIF mode active is depicted in
The neuromonitoring system 10 performs assessments of spinal cord health using one or more of MEP Auto, MEP Manual, and SSEP modes. In MEP modes, stimulation signals are delivered to the Motor Cortex via patient module 14 and resulting EMG responses are detected from various muscles in the upper and lower extremities. An increase in Ithresh from an earlier test to a later test may indicate a degradation of spinal cord function. Likewise, the absence of a significant EMG response to a given Istim on a channel that had previously reported a significant response to the same or lesser Istim is also indicative of a degradation in spinal cord function. These indicators are detected by the system in the MEP modes and reported to the surgeon. In MEP Auto mode the system determines the Ithresh baseline for each channel corresponding to the various monitored muscles, preferably early in the procedure, using the multi-channel algorithm described. Throughout the procedure subsequent tests may be conducted to again determine Ithresh for each channel. The difference between the resulting Ithresh values and the corresponding baseline are computed by the system 10 and compared against predetermined “safe” and “unsafe” difference values. The Ithresh, baseline, and difference values are displayed to the user, along with any other indicia of the safety level determined (such as a red, yellow, green color code), on the display 34, as illustrated in
In SSEP mode, the neuromonitoring system 10 stimulates peripheral sensory nerves that exit the spinal cord below the level of surgery and then measures the electrical action potential from electrodes located on the nervous system tract superior to the surgical target site. To accomplish this, stimulation electrodes 22 may be placed on the skin over the desired peripheral nerve (such as by way of example only, the Posterior Tibial nerve and/or the Ulnar nerve) and recording electrodes 23 are positioned on the recording sites (such as, by way of example only, C2 vertebra, scalp, Erb's point, and pop fossa) and stimulation signals are delivered from the patient module 14. Damage in the spinal cord may disrupt the transmission of the signal up the cord resulting in a weakened or delayed signal at the recording site. The system 10 determines differences in amplitude and latency between a signal response and a baseline signal response. The differences are compared against predetermined “safe” and “unsafe” levels and the results are displayed on display 34 as seen in the exemplary screen view illustrated in
The neuromonitoring system 10 may also conduct free-run EMG monitoring while the system is in any of the above-described modes. Free-run EMG monitoring continuously listens for spontaneous muscle activity that may be indicative of potential danger. The system 10 may automatically cycle into free-run monitoring after 5 seconds (by way of example only) of inactivity. Initiating a stimulation signal in the selected mode will interrupt the free-run monitoring until the system 10 has again been inactive for five seconds, at which time the free-run begins again.
The neuromonitoring system 10 may also perform a navigated guidance function. The navigated guidance feature may be used by way of example only, to ensure safe and reproducible pedicle screw placement by monitoring the axial trajectory of surgical instruments used during pilot hole formation and/or screw insertion. Preferably, EMG monitoring may be performed simultaneously with the navigated guidance feature. To perform the navigated guidance and angle-measuring device (hereafter “tilt sensor”) 54 is connected to the patient module 14 via one of the accessory ports 62. The tilt sensor measures its angular orientation with respect to a reference axis (such as, for example, “vertical” or “gravity”) and the control unit displays the measurements. Because the tilt sensor is attached to a surgical instrument the angular orientation of the instrument, may be determined as well, enabling the surgeon to position and maintain the instrument along a desired trajectory during use. In general, to orient and maintain the surgical instrument along a desired trajectory during pilot hole formation, the surgical instrument is advanced to the pedicle (through any of open, mini-open, or percutaneous access) while oriented in the zero-angle position. The instrument is then angulated in the sagittal plane until the proper cranial-caudal angle is reached. Maintaining the proper cranial-caudal angle, the surgical instrument may then be angulated in the transverse plane until the proper medial-lateral angle is attained. Once the control unit 12 indicates that both the medial-lateral and cranial caudal angles are matched correctly, the instrument may be advanced into the pedicle to form the pilot hole, monitoring the angular trajectory of the instrument until the hole formation is complete.
The control unit 12 may communicate any of numerical, graphical, and audio feedback corresponding to the orientation of the tilt sensor in the sagittal plane (cranial-caudal angle) and in the transverse plane (medial-lateral angle). The medial-lateral and cranial-caudal angle readouts may be displayed simultaneously and continuously while the tilt sensor is in use, or any other variation thereof (e.g. individually and/or intermittently).
To obtain Ithresh and take advantage of the useful information it provides, the system 10 identifies and measures the peak-to-peak voltage (Vpp) of each EMG response corresponding to a given stimulation current (IStim). Identifying the true Vpp of a response may be complicated by the existence of stimulation and/or noise artifacts which may create an erroneous Vpp measurement. To overcome this challenge, the neuromonitoring system 10 of the present invention may employ any number of suitable artifact rejection techniques such as those shown and described in full in the above referenced co-pending and commonly assigned PCT App. Ser. No. PCT/US2004/025550, entitled “System and Methods for Performing Dynamic Pedicle Integrity Assessments,” filed on Aug. 5, 2004, the entire contents of which are incorporated by reference into this disclosure as if set forth fully herein. Upon measuring Vpp for each EMG response, the Vpp information is analyzed relative to the corresponding stimulation current (Istim) in order to identify the minimum stimulation current (Ithresh) capable of resulting in a predetermined Vpp EMG response. According to the present invention, the determination of IThresh may be accomplished via any of a variety of suitable algorithms or techniques.
Additionally, in the “dynamic” functional modes, including, but not necessarily limited to Dynamic Stimulation EMG and XLIF, the system may continuously update the stimulation threshold level and indicate that level to the user. To do so, the threshold hunting algorithm does not repeatedly determine the Ithresh level anew, but rather, it determines whether stimulation current thresholds are changing. This is accomplished, as illustrated in
In an alternative embodiment, rather than beginning by entering the bracketing phase at the minimum stimulation current and bracketing upwards until Ithresh is bracketed, the threshold hunting algorithm may begin by immediately determining the appropriate safety level and then entering the bracketing phase. The algorithm may accomplish this by initiating stimulation at one or more of the boundary current levels. By way of example only, and with reference to
For some functions, such as (by way of example) MEP, it may be desirable to obtain Ithresh for each active channel each time the function is performed. This is particularly advantageous when assessing changes in Ithresh over time as a means to detect potential problems (as opposed to detecting an Ithresh below a predetermined level determined to be safe, such as in the Stimulated EMG modes). While Ithresh can be found for each active channel using the algorithm as described above, it requires a potentially large number of stimulations, each of which is associated with a specific time delay, which can add significantly to the response time. Done repeatedly, it could also add significantly to the overall time required to complete the surgical procedure, which may present added risk to the patient and added costs. To overcome this drawback, a preferred embodiment of the neuromonitoring system 10 boasts a multi-channel threshold hunting algorithm so as to quickly determine Ithresh for each channel while minimizing the number of stimulations and thus reduce the time required to perform such determinations.
The multi-channel threshold hunting algorithm reduces the number stimulations required to complete the bracketing and bisection steps when Ithresh is being found for multiple channels. The multi-channel algorithm does so by omitting stimulations for which the result is predictable from the data already acquired. When a stimulation signal is omitted, the algorithm proceeds as if the stimulation had taken place. However, instead of reporting an actual recruitment result, the reported result is inferred from previous data. This permits the algorithm to proceed to the next step immediately, without the time delay associated with a stimulation signal.
Regardless of what channel is being processed for Ithresh, each stimulation signal elicits a response from all active channels. That is to say, every channel either recruits or does not recruit in response to a stimulation signal (again, a channel is said to have recruited if a stimulation signal evokes an EMG response deemed to be significant on that channel, such as Vpp of approximately 100 uV). These recruitment results are recorded and saved for each channel. Later, when a different channel is processed for Ithresh, the saved data can be accessed and, based on that data, the algorithm may omit a stimulation signal and infer whether or not the channel would recruit at the given stimulation current.
There are two reasons the algorithm may omit a stimulation signal and report previous recruitment results. A stimulation signal may be omitted if the selected stimulation current would be a repeat of a previous stimulation. By way of example only, if a stimulation current of 1 mA was applied to determine Ithresh for one channel, and a stimulation at 1 mA is later required to determine Ithresh for another channel, the algorithm may omit the stimulation and report the previous results. If the specific stimulation current required has not previously been used, a stimulation signal may still be omitted if the results are already clear from the previous data. By way of example only, if a stimulation current of 2 mA was applied to determine Ithresh for a previous channel and the present channel did not recruit, when a stimulation at 1 mA is later required to determine Ithresh for the present channel, the algorithm may infer from the previous stimulation that the present channel will not recruit at 1 mA because it did not recruit at 2 mA. The algorithm may therefore omit the stimulation and report the previous result.
In the interest of clarity,
Once Ithresh is found for channel 1, the algorithm turns to channel 2, as illustrated in
Although the multi-channel threshold hunting algorithm is described above as processing channels in numerical order, it will be understood that the actual order in which channels are processed is immaterial. The channel processing order may be biased to yield the highest or lowest threshold first (discussed below) or an arbitrary processing order may be used. Furthermore, it will be understood that it is not necessary to complete the algorithm for one channel before beginning to process the next channel, provided that the intermediate state of the algorithm is retained for each channel. Channels are still processed one at a time. However, the algorithm may cycle between one or more channels, processing as few as one stimulation current for that channel before moving on to the next channel. By way of example only, the algorithm may stimulate at 10 mA while processing a first channel for Ithresh. Before stimulating at 20 mA (the next stimulation current in the bracketing phase), the algorithm may cycle to any other channel and process it for the 10 mA stimulation current (omitting the stimulation if applicable). Any or all of the channels may be processed this way before returning to the first channel to apply the next stimulation. Likewise, the algorithm need not return to the first channel to stimulate at 20 mA, but instead may select a different channel to process first at the 20 mA level. In this manner, the algorithm may advance all channels essentially together and bias the order to find the lower threshold channels first or the higher threshold channels first. By way of example only, the algorithm may stimulate at one current level and process each channel in turn at that level before advancing to the next stimulation current level. The algorithm may continue in this pattern until the channel with the lowest Ithresh is bracketed. The algorithm may then process that channel exclusively until Ithresh is determined, and then return to processing the other channels one stimulation current level at a time until the channel with the next lowest Ithresh is bracketed. This process may be repeated until Ithresh is determined for each channel in order of lowest to highest Ithresh. If Ithresh for more than one channel falls within the same bracket, the bracket may be bisected, processing each channel within that bracket in turn until it becomes clear which one has the lowest Ithresh. If it becomes more advantageous to determine the highest Ithresh first, the algorithm may continue in the bracketing state until the bracket is found for every channel and then bisect each channel in descending order.
If Ithresh cannot be confirmed, the algorithm enters the bracketing state. Rather than beginning the bracketing state from the minimum stimulation current, however, the bracketing state may begin from the previous Ithresh. The bracketing may advance up or down depending on whether Ithresh has increased or decreased. By way of example only, if the previous value of Ithresh was 4 mA, the confirmation step may stimulate at 4 mA and 3.75 mA. If the stimulation at 4 mA fails to evoke a significant response, it may be concluded that the Ithresh has increased and the algorithm will bracket up from 4 mA. When the algorithm enters the bracketing state, the increment used in the confirmation step (i.e. 0.25 mA in this example) is doubled. Thus, in this example, the algorithm stimulates at 4.50 mA. If the channel fails to recruit at this current level, the increment is doubled again (1 mA in this example) and the algorithm stimulates at 5.50 mA. This process is repeated until the maximum stimulation current is reached or the channel recruits, at which time the bisection function may be performed. If, during the confirmation step, the stimulation current just below the previously determined Ithresh recruits, it may be concluded that Ithresh for that channel has decreased and the algorithm may bracket down from that value (3.75 mA in this case). Thus, in this example, the algorithm would double the increment to 0.50 mA and stimulate at 3.25 mA. If the channel still recruits at this stimulation current, the increment is doubled again to 1 mA such that the algorithm stimulates at 2.25 mA. This process is repeated until the minimum stimulation current is reached or the channel fails to recruit, at which time the algorithm may perform the bisection function. When determining Ithresh for multiple channels with previously determined Ithresh values, this technique may be performed for each channel, in turn, in any order. Again stimulations may be omitted and the algorithm may begin processing a new channel before completing the algorithm for another channel, as described above.
Although the hunting algorithm is discussed herein in terms of finding Ithresh (the lowest stimulation current that evokes a predetermined EMG response), it is contemplated that alternative stimulation thresholds may be useful in assessing the health of the spinal cord or nerve monitoring functions and may be determined by the hunting algorithm. By way of example only, the hunting algorithm may be employed by the system 10 to determine a stimulation voltage threshold, Vstimthresh. This is the lowest stimulation voltage (as opposed to the lowest stimulation current) necessary to evoke a significant EMG response, Vthresh. Bracketing, bisection and monitoring states are conducted as described above for each active channel, with brackets based on voltage being substituted for the current based brackets previously described. Moreover, although described above within the context of MEP monitoring, it will be appreciated that the algorithms described herein may also be used for determining the stimulation threshold (current or voltage) for any other EMG related functions, including but not limited to pedicle integrity (screw test), nerve detection, and nerve root retraction.
The neurophysiology system 10 has been described above according to a preferred embodiment. Nevertheless, various components could be added and/or existing components could be altered without departing from the scope of the invention. Some of these contemplated alterations and/or additions are disclosed hereafter.
One embodiment of a patient module 4814 is illustrated in
The patient module 4914, 5014 is preferably positioned outside of the surgical field but close enough so that all electrode connections can be made without tension on the wires, should a wired connection be used. Optionally, one or more hub stations (hubs) 5124 may be communicatively linked to the patient module 14 and are provided for placement inside the surgical field and/or at the opposite end of the patient from the patient module 14. The addition of hubs 5124 may reduce the presence of wires in wired system or partially wired systems. By way of example only, the patient module 14 may be placed on the edge of the bed near the patient's feet. A wired electrode harness may be connected to the module 14 and individual electrodes may be dispersed over the muscles of the legs. A hub 5124 may be wirelessly connected to the patient module 14 and positioned near the patient's head. Another wired electrode harness may be connected to the hub 5124 and stimulation and/or recoding electrodes may be dispersed over the patient's head (e.g. for MEP and SSEP monitoring). A second hub may be provided and wirelessly connected to the patient module 14. The second hub may be placed near the stimulation site and a stimulation accessory may be connected to it via a wire.
The neurophysiology system 10 utilizes stimulation accessories to deliver stimulation signals to the stimulation target site. The stimulation accessories may be in the form of various probe devices that are themselves inserted to the stimulation site, clips that attach to and deliver stimulation signals to standard instruments that are used at various times throughout a procedure (e.g. pedicle access needle, tap, dilators, tissue retractor, etc. . . . ), and surface electrodes.
The probe handle 6035 shown, by way of example only, in
The probe handle 6135 shown, by way of example only, in
An example embodiment of a joystick probe handle 6235 is illustrated in
Yet another ergonomic probe handle is illustrated, by way of example only in
Attaching an electric coupling device to the neurophysiology system 10, either directly or via a probe handle, allows the neurophysiologic assessments performed by the system 10 to be conducted through various surgical instruments used during a surgical procedure. By way of example only, the coupling device may connect instruments including, but not necessarily limited to, a tap, dilator, tissue retractor, and k-wire, to the neurophysiology system 10. Various example embodiments of electric coupling devices will now be described.
As previously discussed, the neurophysiology system 10 may employ various electrodes to conduct the different the neurophysiologic assessments it performs. By way of example only, the system may employ EMG recording electrodes positioned over various muscles of the body to detect muscle response to stimulation signals. The placement of electrodes depends upon various factors including, for example, the function being performed and the applicable spinal level. By way of example, during lumbar surgery recording electrodes may be positioned over muscles of the lower extremities. For cervical procedures and/or during cord monitoring (e.g. via MEP mode) electrodes may be positioned over muscles of the upper extremities, or a combination of upper extremities and lower extremities. Recording electrodes may also be dispersed over the scalp for monitoring during SSEP mode. In addition to recording electrodes, the neurophysiology system 10 may also utilize stimulation electrodes to deliver stimulation signals to a selected target site. By way of example only, stimulation electrodes may be positioned on the scalp for MEP stimulation. Stimulation electrodes may also be placed over one or more peripheral nerves for SSEP stimulation and/or neuromuscular pathway assessment. While the electrodes have been described as being surface electrodes, it should be appreciated that various other types of electrodes may be used as well, such as, by way of example only, needle electrodes and corkscrew electrodes.
As previously described, the neurophysiology system 10 may preferably employ a color code system wherein each modality has a unique color associated with it. By way of example only and as shown herein, EMG monitoring may be associated with the color green, MEP monitoring with the color blue, and SSEP monitoring with the color orange. Utilizing this color code (or any other possible code, e.g. numerical, etc. . . . ), disposables (i.e. electrodes and harnesses, stimulation accessories, etc. . . . ) may be efficiently packaged for specific modalities. The electrodes within the package may be tagged accordingly and unnecessary components may be left out. In one embodiment, illustrated by way of example in
A variety of secondary feedback devices may be provided with the system 10. With reference to
With reference to
In one example, visual feedback may be accomplished via a LED based display. Multiple colored LEDS such as, red, yellow, and, green LEDS may be included to incorporate the color code relating to different safety levels, as discussed above. The SND may emit an audible sound that corresponds to different threshold results. The pitch of the sound may change in response to different threshold levels. For example, when a determined threshold is in the safe (Green) range then a low pitch tone may be emitted. When the threshold result is in-between the safe and unsafe levels (Yellow) the sound may have a higher pitch. A still higher pitch may be emitted when the threshold result is in the unsafe (Red) range. Alternatively, a different sound volume may indicate different safety levels. In still another alternative, different sounds (e.g. ping, bell, siren etc. . . . ) may be produced for each safety level. The vibratory action of the sensory notification device may operate in similar fashion to that of the sound function just described. That is, the vibration frequency and/or intensity may be altered depending on the safety level of the corresponding threshold result.
While this invention has been described in terms of a best mode for achieving this invention's objectives, it will be appreciated by those skilled in the art that variations may be accomplished in view of these teachings without deviating from the spirit or scope of the present invention. For example, the present invention may be implemented using any combination of computer programming software, firmware or hardware. As a preparatory step to practicing the invention or constructing an apparatus according to the invention, the computer programming code (whether software or firmware) according to the invention will typically be stored in one or more machine readable storage mediums such as fixed (hard) drives, diskettes, optical disks, magnetic tape, semiconductor memories such as ROMs, PROMs, etc., thereby making an article of manufacture in accordance with the invention. The article of manufacture containing the computer programming code is used by either executing the code directly from the storage device, by copying the code from the storage device into another storage device such as a hard disk, RAM, etc. or by transmitting the code on a network for remote execution. As can be envisioned by one of skill in the art, many different combinations of the above may be used and accordingly the present invention is not limited by the specified scope.
1. A system for avoiding harm to nervous tissue during surgery, comprising:
- an instrument capable of advancement to a surgical target site and configured to deliver a stimulation signal at least one of while advancing to said target site and after reaching said target site; and
- a processing system programmed with a set of at least three threshold ranges and configured to direct a first stimulation signal to said instrument at a first magnitude corresponding to a boundary between a pair of said ranges, direct a second stimulation signal at a second magnitude corresponding to a boundary between a different pair of said ranges, and to measure at least one response of nerves depolarized by said stimulation signals to indicate at least one of nerve proximity and pedicle integrity.
2. The system of claim 1, wherein the at least one response of said depolarized nerves is measured by monitoring EMG waveforms of myotomes associated with said depolarized nerves.
3. The system of claim 1, wherein said system includes a display for communicating said at least one of nerve proximity and pedicle integrity.
4. The system of claim 3, wherein said system indicates at least one of nerve proximity and pedicle integrity by displaying at least one of the colors red, yellow, and green.
5. The system of claim 4, wherein said processing system automatically determines a stimulation threshold after displaying said one of red, yellow, and green.
6. The system of claim 5, wherein said processing system augments the display of said one of red, yellow, and green with a numerical value after determining said threshold.
7. The system of claim 1, wherein said instrument is a device for forming a hole in a pedicle.
8. The system of claim 7, wherein said instrument is further coupled to an orientation sensor operable to determine a first angular relationship in a first plane between said sensor and a reference direction and operable to determine a second angular relationship in a second plane between said sensor and said reference direction.
9. The system of claim 8, wherein said orientation sensor is communicatively linked to said processing system.
10. The system of claim 8, wherein said processing unit communicates information to a user regarding at least one of said determined first and second angular relationships between said sensor and said reference direction.
11. The system of claim 1, wherein said instrument is part of a system for establishing an operative corridor to a surgical target site.
12. The system of claim 11, wherein said operative corridor is a lateral approach to a spinal target site.
13. The system of claim 12, wherein said instrument is further coupled to an orientation sensor operable to determine a first angular relationship in a first plane between said sensor and a reference direction and operable to determine a second angular relationship in a second plane between said sensor and said reference direction, wherein said orientation sensor is communicatively linked to said processing system, and said processing unit communicates information to a user regarding at least one of said determined first and second angular relationships between said sensor and said reference direction.
14. The system of claim 1, wherein an individualized closed circuit is formed between the instrument and the processing system.
15. The system of claim 14, wherein at least one of said processing system and said instrument possess an indicator when said closed circuit is formed.
16. The system of claim 15, wherein said indicator is an LED.
17. The system of claim 1, comprising a plurality of sensors for measuring said nerve responses.
18. The system of claim 17, wherein said plurality of sensors comprises at least one of an anode and a common electrode.
19. The system of claim 18, wherein said plurality of sensors connect to said processing system through a single connector.
20. The system of claim 19, wherein said single connector comprises an identifier that is recognized by said processing unit.
21. The system of claim 20, wherein the identification of said connector alters system parameters employed by said processing system.
22. The system of claim 18, wherein the status of said sensors is checked prior to measuring said nerve responses.
23. The system of claim 22, wherein said status is checked with an impedance measurement.
24. The system of claim 23, wherein the status of every sensor is determined independently from the other sensors.
25. The system of claim 24, wherein said anode sensor switches to a cathode to measure impedance.
26. The system of claim 18, further comprising at least one additional sensor not for measuring nerve responses.
27. The system of claim 26, wherein said sensor is a stimulation electrode.
28. The system of claim 27, wherein said sensor delivers stimulation to a peripheral nerve.
29. The system of claim 28, said sensor delivers stimulation signals to the motor cortex.
30. The system of claim 1, wherein said processing system is further configured to: (a) deliver an electrical stimulation signal to the motor cortex of a patient; (b) receive evoked neuromuscular response data from a sensor employed on the patient; (c) assess spinal cord health by identifying a relationship between the stimulation signal and the neuromuscular response; and
- (d) communicate the relationship between the stimulation signal and the neuromuscular response to a user via at least one of alpha-numeric indicia and audio.
31. The system of claim 1, wherein said processing system is further configured to: (a) deliver an electrical stimulation signal to a peripheral nerve of the patient; (b) measure an action potential related to said stimulation signal; (c) assess spinal cord health by identifying a relationship between the stimulation signal and the measured action potential; and (d) communicate the relationship between the stimulation signal and the action potential response to a user via at least one of alpha-numeric indicia and audio.
32. The system of claim 30, wherein said processing system is further configured to: (a) deliver an electrical stimulation signal to a peripheral nerve of the patient; (b) measure an action potential related to said stimulation signal; (c) assess spinal cord health by identifying a relationship between the stimulation signal and the measured action potential; and (d) communicate the relationship between the stimulation signal and the action potential response to a user via at least one of alpha-numeric indicia and audio.
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Filed: Apr 3, 2008
Date of Patent: Aug 28, 2012
Patent Publication Number: 20090054804
Assignee: NuVasive, Inc. (San Diego, CA)
Inventors: James Gharib (San Diego, CA), Allen Farquhar (San Diego, CA), Doug Layman (San Diego, CA), Thomas Scholl (San Diego, CA), Albert Kim (San Diego, CA), Albert Pothier (San Diego, CA), Patrick Miles (San Diego, CA), Josef Gorek (Oakland, CA), Mark Peterson (San Diego, CA)
Primary Examiner: Sean Dougherty
Attorney: Jonathan Spangler
Application Number: 12/080,630
International Classification: A61B 5/04 (20060101); A61B 5/05 (20060101); A61B 18/04 (20060101); A61B 18/18 (20060101); A61N 1/00 (20060101);